Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
clarithromycin, Quantity: 500 mg
Sandoz Pty Ltd
Clarithromycin
Tablet, film coated
Excipient Ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; croscarmellose sodium; macrogol 4000; hypromellose; titanium dioxide; microcrystalline cellulose; powdered cellulose
Oral
100, 14, 42
(S4) Prescription Only Medicine
CLARITHROMYCIN SANDOZ clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: Acute streptococcal pharyngitis; Community acquired pneumonia due to Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophilia and Streptococcus pneumoniae;Uncomplicated skin and skin structure infections due to Staphylococcus aureus or Streptococcus pyogenes;Disseminated or localised mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare and skin and skin structure infections due to Mycobacterium chelonae. Clarithromycin should be used in combination with other anti mycobacterial agents.Prevention of disseminated Mycobacterium avium complex infection in HIV infected adults with CD4 lymphocyte counts <75 cells/mm 3 (See Precautions). Disseminated infection due to Mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae;Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. CLARITHROMYCIN SANDOZ clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro organisms in the conditions listed below:Acute streptococcal pharyngitis and tonsillitis caused by Streptococcus pyogenes; Community acquired pneumonia including infections due to Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila; Skin and skin structure infections (eg impetigo); Disseminated or localised infections due to Mycobacterium avium or Mycobacterium intracellulare in immunocompromised children, including those with HIV Infection or AIDS. Acute otitis media.Note:1. Penicillins are the drug of first choice in the treatment of acute otitis media. 2. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. Clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. There is insufficient evidence of efficacy to support the use of Clarithromycin in acute bronchitis in young children. 4. The data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.
Visual Identification: White, oblong, convex tablets, scored on both faces; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2005-08-29
Clarithromycin Sandoz® 1 CLARITHROMYCIN SANDOZ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING CLARITHROMYCIN SANDOZ? Clarithromycin Sandoz contains the active ingredient clarithromycin. Clarithromycin Sandoz is used to treat certain bacterial infections including respiratory tract infections, ear infections, skin infections and peptic ulcer. Clarithromycin Sandoz is used to prevent a specific bacterial infection associated with HIV infection. For more information, see Section 1. Why am I using Clarithromycin Sandoz? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CLARITHROMYCIN SANDOZ? Do not use if you have ever had an allergic reaction to clarithromycin, other antibiotics from the macrolide family or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Clarithromycin Sandoz? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Clarithromycin Sandoz and affect how it works or may be affected by Clarithromycin Sandoz. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CLARITHROMYCIN SANDOZ? Your doctor will tell you how much to take and when to take it. Take Clarithromycin Sandoz exactly as directed by your doctor. More instructions can be found in Section 4. How do I use Clarithromycin Sandoz? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CLARITHROMYCIN SANDOZ? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist that you visit that you are using Clarithromycin Sandoz. • Tell your doctor if you are taking Clarithromycin Sandoz for an infection and your symptoms do not improve within a few days, or they become worse, you become Прочитать полный документ
_Product Information _ _ _ _Page_ 1 _Clarithromycin Sandoz 250mg, 500mg tablets _ _11/2017 _ _ _ _Sandoz Pty Ltd_ PRODUCT INFORMATION CLARITHROMYCIN SANDOZ 250MG AND 500MG TABLETS NAME OF THE MEDICINE Generic name: Clarithromycin. Chemical name: (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)–4-[(2,6-Dideoxy-3-C-methyl-3-O- methyl- -L-ribo-hexopyranosyl)oxy]-14-ethyl-12,13-dihydroxy-7-methoxy-3,5,7,9,11,13- hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo- hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione Other names 6-O-methylerythromycin A Chemical structure: CAS number 81103-11-9 C 38 H 69 NO 13 MW:747.95 g/mol DESCRIPTION Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol and acetonitrile and practically insoluble in water. In addition to clarithromycin, Clarithromycin Sandoz tablets contain: cellulose-microcrystalline, magnesium stearate, croscarmellose sodium, cellulose-powdered, silica-colloidal anhydrous, lactose monohydrate, hypromellose, macrogol 4000 and titanium dioxide. _Product Information _ _ _ _Page_ 2 _Clarithromycin Sandoz 250mg, 500mg tablets _ _11/2017 _ _ _ _Sandoz Pty Ltd_ PHARMACOLOGY Clarithromycin is a semi-synthetic macrolide antibiotic. Hepatotoxicity, atrophy of lymphatic tissues (lymph, thymus) and adverse reproductive toxicity were seen in several species at exposures less than those which might be expected clinically at proposed doses. The clinical significance of these observations is not known. There are no data from long term animal carcinogenicity studies. _CLINICAL PHARMACOLOGY_ _Helicobacter pylori_ is strongly associated with peptic ulcer disease. Ninety to 100% of patients with peptic ulcers are infected with this pathogen. Eradication of _H. pylori _ is associated with a reduction in the rate of duodenal ulcer recurrence, thereby reducing the need for maintenance anti-secretory therapy. The development of antimicrobial resistance may have an adverse effect on eradication regimens. The clinical impact Прочитать полный документ